Stability Officer
Core
Conducting stability studies to ensure product shelf-life across export markets, investigating deviations, and advising on the impact of process changes on stability.
Role type
Quality Systems Stability Officer
Builds
Stability data and protocols supporting regulatory registrations and product lifecycle management
Domain
Pharmaceutical manufacturing and quality assurance
Required skills
stability study design and execution, deviation investigation, statistical evaluation, protocol writing, regulatory compliance knowledge, data analysis, change impact assessment, climate chamber monitoring
Preferred skills
cGMP regulations, analytical and microbiological testing knowledge
Technologies
LIMS, climate chambers, statistical software
Responsibilities
Coordinate and plan new and ongoing stability studies; prepare stability protocols; evaluate results and escalate deviations; investigate out-of-trend results and determine follow-up actions; write statistical evaluations for product reviews; advise on the stability impact of process or packaging changes; handle data requests from regulatory teams; monitor climate chamber operations; propose optimizations for stability workflows; stay updated on stability study requirements.
